Eyedrop Instillation Technique

NCT ID: NCT01417689

Last Updated: 2011-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-03-31

Brief Summary

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Eye drop instillation is a problem from glaucoma patients. Studies reveal that 30-50% of glaucoma patients have problems instilling their eyedrops. These problems include not hitting the eye, spending many drops to get a single successful instillation and bottle contamination.

The present study will evaluate the effect of encouraging patients to put their eyedrops using one of 2 techniques, randomly assigned, to determine which is more successful at instilling the eye drop into the eye while spending the least amount of drug.

In one of the techniques the patient instills the eye drop with their eyes open in the inferior cul de sac. In the other technique the patient instills the eye drop with the eyes closed near the inner canthal region.

Patients will be randomized to encouragement to use the drops with either of the techniques. Encouragement will take place over a visit where they will be subjected to:

* Baseline evaluation of eye drop instillation using their usual technique.
* Short (2-5 minute) educational session session for the assigned technique.
* Followup evaluation immediately after the educational session.

Detailed Description

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Conditions

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Glaucoma Glaucoma Suspect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Open-eyes

Patients in this arm are encourage to attempt eye drop instillation using the most commonly used technique that involves looking up, pulling inferior lid down and putting the drop in the inferior cul de sac.

Group Type ACTIVE_COMPARATOR

Encouragement to attempt eye drop instillation with a specific technique

Intervention Type OTHER

Encouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes.

Closed-eyes

Patients in this group are encouraged to attempt eye drop instillation with both eyes closed near the medial canthal region. After feeling contact with the drop on the skin the drop is expected to enter the eye when opening the eye and resuming blinking.

Group Type EXPERIMENTAL

Encouragement to attempt eye drop instillation with a specific technique

Intervention Type OTHER

Encouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes.

Interventions

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Encouragement to attempt eye drop instillation with a specific technique

Encouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Glaucoma or glaucoma suspect
* Use of topical glaucoma medication in both eyes for at least 1 year prior to enrollment
* VA of 20/60 or better with habitual correction in at least one eye

Exclusion Criteria

* Previous history of allergy to fluorescein
* Received topical anesthesia for IOP measurement or other reason within the last 2 hours.
* Rejects participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oftalmologia Hospital Sotero del Rio

OTHER

Sponsor Role lead

Responsible Party

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1 Pontificia Universidad Catolica de Chile, 2 Hospital Sotero del Rio.

Principal Investigators

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Eugenio A Maul, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile. Hospital Sotero del Rio.

Locations

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Hospital Sotero del Rio

Santiago, RM, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Militza Sanchez, COT

Role: CONTACT

+56982382507

Facility Contacts

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Eugenio A Maul, MD MPH

Role: primary

+56966593935

Other Identifiers

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Oftalmo_Glaucoma_001

Identifier Type: -

Identifier Source: org_study_id

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